medical Class II Updated 2024-10-30

MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand medical procedure convenience kits, labeled as

Recalled Product

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF DYNJ07831F; 7) DELIVERY PACK-LF, REF DYNJ09982A; 8) DELIVERY PACK-LF, REF DYNJ09982A; 9) DELIVERY ROOM PACK, REF DYNJ14193C; 10) OB PACK, REF DYNJ17486I; 11) OB PACK, REF DYNJ17486I; 12) DELIVERY PACK, REF DYNJ24339K; 13) DELIVERY PACK, REF DYNJ26935A; 14) DELIVERY PACK, REF DYNJ26935A; 15) OB/DELIVERY ROOM PACK, REF DYNJ27262F; 16) VAGINAL DELIVERY TRAY, REF DYNJ27275; 17) VAGINAL DELIVERY, REF DYNJ28437F; 18) OB PACK, REF DYNJ31817K; 19) OB PACK, REF DYNJ31817K; 20) OB PACK, REF DYNJ36010F; 21) OB PACK, REF DYNJ38804G; 22) VAGINAL PACK, REF DYNJ40037A; 23) VAGINAL DELIVERY, REF DYNJ40170A; 24) VAG RECTAL PACK BWH-LF, REF DYNJ41694B; 25) OB DELIVERY PACK, REF DYNJ41994; 26) DELIVERY BUNDLE KIT, REF DYNJ43370A; 27) DELIVERY ROOM PACK, REF DYNJ44328G; 28) OB PACK, REF DYNJ44500F; 29) DELIVERY PACK, REF DYNJ47621A; 30) OB PACK, REF DYNJ50482G; 31) DELIVERY PACK, REF DYNJ52966C; 32) DELIVERY PACK, REF DYNJ57567; 33) LABOR & DELIVERY PACK, REF DYNJ57598; 34) OB DELIVERY PACK, REF DYNJ60784B; 35) VAGINAL DELIVERY PACK, REF DYNJ61662; 36) VAGINAL DELIVERY PACK, REF DYNJ61662; 37) LABOR AND DELIVERY PACK, REF DYNJ61864A; 38) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 39) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 40) VUWC OB PACK, REF DYNJ64017B; 41) OB PACK, REF DYNJ65525B; 42) VAG DELIVERY PACK, REF DYNJ66415; 43) VAGINAL DELIVERY PACK, REF DYNJ66970; 44) VAG DELIVERY, REF DYNJ67089; 45) VAGINAL DELIVERY PACK, REF DYNJ67111; 46) VAGINAL DELIVERY PACK, REF DYNJ67111; 47) AOMC MIDWIFE PACK, REF DYNJ67588; 48) VAGINAL DELIVERY TRAY, REF DYNJ68131A; 49) DELIVERY L&D PACK-CLEAR LAKE, REF DYNJ68247C; 50) DELIVERY L & D PACK, REF DYNJ68251D; 51) DELIVERY L & D PACK, REF DYNJ68251D; 52) SS VAGINAL DELIVERY PACK, REF DYNJ69512; 53) VAGINAL DELIVERY PACK, REF DYNJ69544A; 54) DELIVERY, REF DYNJ69721; 55) VAGINAL PACK, REF DYNJ69774A; 56) LABOR & DELIVERY PACK, REF DYNJ69833; 57) VAGINAL DELIVERY, REF DYNJ80532A; 58) OB PACK, REF DYNJ81878; 59) VAGINAL DELIVERY DISP PACK, REF DYNJ81917; 60) GENERAL DELIVERY PACK, REF DYNJ82447; 61) VAGINAL DELIVERY PACK, REF DYNJ82489B; 62) OB PACK, REF DYNJ82923; 63) OB PACK III, REF DYNJ82945; 64) OB PACK, REF DYNJ83196; 65) OB PACK, REF DYNJ83515; 66) 3027240 OB DELIVERY PACK, REF DYNJ84730; 67) DELIVERY PACK, REF DYNJ85860; 68) LABOR AND DELIVERY, REF DYNJ907794A; 69) LABOR AND DELIVERY, REF DYNJ907794A; 70) LABOR AND DELIVERY, REF DYNJ907794A; 71) VAGINAL DELIVERY, REF DYNJ908636A; 72) LABOR & DELIVERY PK I-LF, REF DYNJT0104G; 73) PACK VAGINAL DELIVERY, REF HM190A; 74) VAGINAL DELIVERY PACK-LF, REF PHS410140008D; 75) VAGINAL DELIVERY PACK, REF SYNJ10248B; 76) VAGINAL DELIVERY PACK, REF SYNJ10248B

Hazard / Issue

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) REF DYNJ0213264O, UDI/DI 40193489411912 (each), 10193489411911 (case), Lot Numbers: 23LBP214; 2) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23LBQ906; 3) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23KBO506; 4) REF DYNJ04865M, UDI/DI 40195327188123 (each), 10195327188122 (case), Lot Numbers: 23LBP871; 5) REF DYNJ0536939R, UDI/DI 40195327206223 (each), 10195327206222 (case), Lot Numbers: 24ABC134; 6) REF DYNJ07831F, UDI/DI 40888277841131 (each), 10888277841130 (case), Lot Numbers: 24ABK556; 7) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 24ABE463; 8) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 23KBF261; 9) REF DYNJ14193C, UDI/DI 40195327410002 (each), 10195327410001 (case), Lot Numbers: 24ABA112; 10) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23LBM930; 11) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23KBF343; 12) REF DYNJ24339K, UDI/DI 40195327597352 (each), 10195327597351 (case), Lot Numbers: 24ABB322; 13) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 24ABF439; 14) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 23KBF264; 15) REF DYNJ27262F, UDI/DI 40195327302925 (each), 10195327302924 (case), Lot Numbers: 23LBR393; 16) REF DYNJ27275, UDI/DI 40080196833116 (each), 10080196833115 (case), Lot Numbers: 24ABF229; 17) REF DYNJ28437F, UDI/DI 40193489800518 (each), 10193489800517 (case), Lot Numbers: 23LBP215; 18) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE494; 19) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE736; 20) REF DYNJ36010F, UDI/DI 40195327409907 (each), 10195327409906 (case), Lot Numbers: 23KBO470; 21) REF DYNJ38804G, UDI/DI 40195327113101 (each), 10195327113100 (case), Lot Numbers: 24ABF285; 22) REF DYNJ40037A, UDI/DI 40889942253792 (each), 10889942253791 (case), Lot Numbers: 23KBD900; 23) REF DYNJ40170A, UDI/DI 40195327007981 (each), 10195327007980 (case), Lot Numbers: 24ABH933; 24) REF DYNJ41694B, UDI/DI 40193489662819 (each), 10193489662818 (case), Lot Numbers: 23KBI386; 25) REF DYNJ41994, UDI/DI 40884389912509 (each), 10884389912508 (case), Lot Numbers: 23KBM567; 26) REF DYNJ43370A, UDI/DI 40888277854124 (each), 10888277854123 (case), Lot Numbers: 24ABE458; 27) REF DYNJ44328G, UDI/DI 40195327165940 (each), 10195327165949 (case), Lot Numbers: 24ABA443; 28) REF DYNJ44500F, UDI/DI 40193489905497 (each), 10193489905496 (case), Lot Numbers: 24ABG242; 29) REF DYNJ47621A, UDI/DI 40193489203418 (each), 10193489203417 (case), Lot Numbers: 23LBM902; 30) REF DYNJ50482G, UDI/DI 40195327190188 (each), 10195327190187 (case), Lot Numbers: 24ABE007; 31) REF DYNJ52966C, UDI/DI 40193489237154 (each), 10193489237153 (case), Lot Numbers: 23LBP186; 32) REF DYNJ57567, UDI/DI 40889942753209 (each), 10889942753208 (case), Lot Numbers: 23LBP083; 33) REF DYNJ57598, UDI/DI 40889942756248 (each), 10889942756247 (case), Lot Numbers: 24ABN293; 34) REF DYNJ60784B, UDI/DI 40195327456444 (each), 10195327456443 (case), Lot Numbers: 23KBD079; 35) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 24ABA680; 36) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 23LBP067; 37) REF DYNJ61864A, UDI/DI 40195327213481 (each), 10195327213480 (case), Lot Numbers: 23LBM885; 38) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23LBN089; 39) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23KBC461; 40) REF DYNJ64017B, UDI/DI 40195327550326 (each), 10195327550325 (case), Lot Numbers: 24ABC789; 41) REF DYNJ65525B, UDI/DI 40195327403332 (each), 10195327403331 (case), Lot Numbers: 23LBP080; 42) REF DYNJ66415, UDI/DI 40193489353182 (each), 10193489353181 (case), Lot Numbers: 23KBE863; 43) REF DYNJ66970, UDI/DI 40193489384636 (each), 10193489384635 (case), Lot Numbers: 24ABA626; 44) REF DYNJ67089, UDI/DI 40193489385497 (each), 10193489385496 (case), Lot Numbers: 23KBF696; 45) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 24ABB663; 46) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 23KBB422; 47) REF DYNJ67588, UDI/DI 40193489416931 (each), 10193489416930 (case), Lot Numbers: 24ABE006; 48) REF DYNJ68131A, UDI/DI 40195327453849 (each), 10195327453848 (case), Lot Numbers: 23LBS187; 49) REF DYNJ68247C, UDI/DI 40195327507665 (each), 10195327507664 (case), Lot Numbers: 23KBF880; 50) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23LBM746; 51) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23KBE824; 52) REF DYNJ69512, UDI/DI 40193489949248 (each), 10193489949247 (case), Lot Numbers: 23LBP605; 53) REF DYNJ69544A, UDI/DI 40195327325368 (each), 10195327325367 (case), Lot Numbers: 23LBU620; 54) REF DYNJ69721, UDI/DI 40193489973076 (each), 10193489973075 (case), Lot Numbers: 24ABA088; 55) REF DYNJ69774A, UDI/DI 40195327328369 (each), 10195327328368 (case), Lot Numbers: 23KBM418; 56) REF DYNJ69833, UDI/DI 40193489983419 (each), 10193489983418 (case), Lot Numbers: 23LBP238; 57) REF DYNJ80532A, UDI/DI 40195327064649 (each), 10195327064648 (case), Lot Numbers: 23KBD408; 58) REF DYNJ81878, UDI/DI 40195327153572 (each), 10195327153571 (case), Lot Numbers: 23LBR963; 59) REF DYNJ81917, UDI/DI 40195327155347 (each), 10195327155346 (case), Lot Numbers: 24ABG346; 60) REF DYNJ82447, UDI/DI 40195327196951 (each), 10195327196950 (case), Lot Numbers: 23KBF548; 61) REF DYNJ82489B, UDI/DI 40195327361298 (each), 10195327361297 (case), Lot Numbers: 23LBJ943; 62) REF DYNJ82923, UDI/DI 40195327219421 (each), 10195327219420 (case), Lot Numbers: 24ABG248; 63) REF DYNJ82945, UDI/DI 40195327218868 (each), 10195327218867 (case), Lot Numbers: 23LBP176; 64) REF DYNJ83196, UDI/DI 40195327243976 (each), 10195327243975 (case), Lot Numbers: 24ABE294; 65) REF DYNJ83515, UDI/DI 40195327275045 (each), 10195327275044 (case), Lot Numbers: 24ABD211; 66) REF DYNJ84730, UDI/DI 40195327407712 (each), 10195327407711 (case), Lot Numbers: 23LBN461; 67) REF DYNJ85860, UDI/DI 40195327560233 (each), 10195327560232 (case), Lot Numbers: 23LBP250; 68) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24EBF501; 69) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24BBS293; 70) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 23KBT943; 71) REF DYNJ908636A, UDI/DI 40195327314980 (each), 10195327314989 (case), Lot Numbers: 23LBE142; 72) REF DYNJT0104G, UDI/DI 40889942741442 (each), 10889942741441 (case), Lot Numbers: 23LBL842; 73) REF HM190A, UDI/DI 40195327305162 (each), 10195327305161 (case), Lot Numbers: 23LBP164; 74) REF PHS410140008D, UDI/DI 40195327503131 (each), 10195327503130 (case), Lot Numbers: 23KBS958; 75) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 24ABA624; 76) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 23KBE181
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